The PRIME trial protocol: evaluating the impact of an intervention implemented in public health centres on management of malaria and health outcomes of children using a cluster-randomised design in Tororo, UgandaReport as inadecuate

The PRIME trial protocol: evaluating the impact of an intervention implemented in public health centres on management of malaria and health outcomes of children using a cluster-randomised design in Tororo, Uganda - Download this document for free, or read online. Document in PDF available to download.

Implementation Science

, 8:114

First Online: 30 September 2013Received: 29 July 2013Accepted: 19 September 2013DOI: 10.1186-1748-5908-8-114

Cite this article as: Staedke, S.G., Chandler, C.I., DiLiberto, D. et al. Implementation Sci 2013 8: 114. doi:10.1186-1748-5908-8-114


BackgroundIn Africa, inadequate health services contribute to the lack of progress on malaria control. Evidence of the impact of interventions to improve health services on population-level malaria indicators is needed. We are conducting a cluster-randomised trial to assess whether a complex intervention delivered at public health centres in Uganda improves health outcomes of children and treatment of malaria, as compared to the current standard of care.

Methods-DesignTwenty public health centres level II and III in Tororo district will be included; 10 will be randomly assigned to the intervention and 10 to control. Clusters will include households located within 2 km of health centres. The trial statistician will generate the random allocation sequence and assign clusters. Health centres will be stratified by level, and restricted randomisation will be employed to ensure balance on cluster location and size. Allocation will not be blinded. The intervention includes training in health centre management, fever case management with use of rapid diagnostic tests RDTs for malaria, and patient-centered services, and provision of artemether-lumefantrine AL and RDTs when stocks run low. The impact of the intervention on population-level health indicators will be assessed through community surveys conducted at baseline in randomly selected children from each cluster, and repeated annually for two years. The impact on individuals over time will be assessed in a cohort study of children recruited from households randomly selected per cluster. The impact on health centres will be assessed using patient exit interviews, monthly surveillance, and assessment of health worker knowledge and skills. The primary outcome is the prevalence of anaemia haemoglobin <11.0 g-dL in individual children under five measured in the annual community surveys. The primary analysis will be based on the cluster-level results.

DiscussionThe PRIME trial findings will be supplemented by the PROCESS study, an evaluation of the process, context, and wider impact of the PRIME intervention which will be conducted alongside the main trial, together providing evidence of the health impact of a public sector intervention in Uganda.

Trial registration and fundingThis trial is registered at NCT01024426 and is supported by the ACT Consortium.

KeywordsMalaria Complex intervention Cluster-randomised trial Uganda Public sector AbbreviationsACTArtemisinin-based combination therapy


HCHealth centre

HCMHealth centre management

HMISHealth management information systems

JUMPJoint Uganda malaria program

IRBInstitutional review board

LSHTMLondon school of hygiene and tropical medicine

MoHMinistry of health

MUMakerere university Kampala, Uganda

MandEMonitoring and evaluation

NMSNational medical stores

OPDOut-patient department

PCSPatient-centered services

PDAPersonal data assistant

RDTRapid diagnostic test

SAESerious adverse event

SOMRECSchool of medicine research and ethical committee Makerere University

SUSARSuspected unexpected serious adverse reaction

UCSFUniversity of California, San Francisco

UNCSTUganda national council of science and technology

WHOWorld Health Organization.

Electronic supplementary materialThe online version of this article doi:10.1186-1748-5908-8-114 contains supplementary material, which is available to authorized users.

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Author: Sarah G Staedke - Clare IR Chandler - Deborah DiLiberto - Catherine Maiteki-Sebuguzi - Florence Nankya - Emily Webb - Gran


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